UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055432 |
|---|---|
| Receipt number | R000063341 |
| Scientific Title | Investigation of the possibility of identifying the change in emotion induced by the aroma of lactobacillus beverages by facial skin blood flow, and the effect of hunger and satiety of the subject on the change in emotion induced by the aroma of lactobacillus beverages. |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2024/09/05 16:38:56 |
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Basic information
Public title
Investigation of the possibility of identifying the change in emotion induced by the aroma of lactobacillus beverages by facial skin blood flow, and the effect of hunger and satiety of the subject on the change in emotion induced by the aroma of lactobacillus beverages.
Acronym
Investigation of the possibility of identifying the change in emotion induced by the aroma of lactobacillus beverages by facial skin blood flow.
Scientific Title
Investigation of the possibility of identifying the change in emotion induced by the aroma of lactobacillus beverages by facial skin blood flow, and the effect of hunger and satiety of the subject on the change in emotion induced by the aroma of lactobacillus beverages.
Scientific Title:Acronym
Investigation of the possibility of identifying the change in emotion induced by the aroma of lactobacillus beverages by facial skin blood flow.
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, improvement of mental health, especially psychological care for Japanese women in their 20s, has become an issue. Various studies have reported that listening to music and forest bathing have relaxing effects, but it is difficult for college students and workers in their 20s to perform these activities during classes or at work. Kawaguchi et al. suggested that the aroma of lactobacillus beverages may predominate parasympathetic nervous activity and increase subjective relaxation in animals and humans. Since commercially available lactobacillus beverages are readily available, if the relaxation effect can be achieved solely by the aroma, they hold great promise as a psychological care tool that can be easily incorporated into the lives of college students and working adults in their 20s.
Facial skin blood flow has attracted attention as a tool that can capture changes in emotion without being masked by voluntary facial expression control. We have shown that pleasant emotions associated with the ingestion of umami and sweet tastes increase eyelid blood flow, while unpleasant emotions associated with the ingestion of bitter tastes decrease nasal blood flow. However, it is unclear whether facial cutaneous blood flow can identify changes in affect to aroma rather than taste stimulation via taste buds. In this study, we examine whether the aroma of lactobacillus beverages induces changes in emotions such as relaxation in female college students in their 20s, and whether these changes are associated with changes in facial skin blood flow.
Basic objectives2
Others
Basic objectives -Others
While the aroma of lactobacillus beverages may bring about a relaxing effect, it is not clear how the effect is affected by differences in the degree of hunger and satiety of the subjects. Fragrances that produce a relaxing effect when inhaled on an empty stomach may also cause discomfort on a full stomach. In addition to the above, the purpose of this study is to examine the effects of the subject's hunger and satiety on the emotional effects of lactobacillus beverage aroma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Facial skin blood flow
Blood pressure
Heart Rate
Heart Rate Variability
Frontal Cerebral Blood Flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
inhalation of lactobacillus beverage aroma
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
healthy female university students
Key exclusion criteria
underlying diseases
smoking habit
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miyaji |
| Middle name | |
| Last name | Akane |
Organization
Tokyo Healthcare university
Division name
Division of Medical nutrition
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo
TEL
03-5799-3711
a-miyaji@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Miyaji |
| Middle name | |
| Last name | Akane |
Organization
Tokyo Healthcare university
Division name
Division of Medical nutrition
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo
TEL
03-5799-3711
Homepage URL
a-miyaji@thcu.ac.jp
Sponsor or person
Institute
Tokyo healthcare university
Institute
Department
Personal name
Funding Source
Organization
Tokyo healthcare university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
tokyo healthcare university
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo
Tel
03-5799-3711
rinri@thcu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医療保健大学世田谷キャンパス
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063341
